Biopharma Business News

The company is investing billions of dollars to construct a European biosimilar hub capable of supporting the rapid expansion of its portfolio.

September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on t…

Solstice Oncology, founded in February, is emerging from stealth having already secured an investigational new drug application from the FDA for a Phase 2 trial of a CTLA-4 antibody purchased from China’s Harbour BioMed.

Kura Oncology has spun out Caspian around KO-7246, which seeks to increase the number and activity of beta cells in the pancreas, in turn boosting insulin production in patients with diabetes.

As geopolitical tensions between the U.S. and China grow increasingly complicated, here are five alternative territories for biotech investments.

Biotech crossover rounds could top $4.22 billion across about 28 rounds this year, PitchBook forecasts.

Moonwalk Biosciences plans to shepherd its lead obesity asset into first-in-human trials in late 2027. In preclinical studies, MW101 has demonstrated weight loss and fat reduction while maintaining muscle mass.

BrainChild Bio’s lead asset BCB-276 is in pivotal development for diffuse intrinsic pontine glioma, a rare and fatal brain tumor that affects around 300 children in the U.S. every year.

Contract development and manufacturing organizations looking to do business with biopharmas include Lonza, which has more than 30 sites, and Samsung Biologics, which recently announced a planned acquisition of another CDMO.

Seven of the 10 companies participating in the fall cohorts of MassBio and SCbio’s Drive program are based in the United States, including four in Massachusetts.

With M&A rising, venture capital returning and policy risks easing, biotech is on a positive trajectory following a prolonged post-pandemic slump, Truist Securities declared after a survey of sector leaders.

The co-development deal comes after Pfizer reported a late-stage failure for a Seagen asset and the discontinuation of another investigational therapy developed by the company as a subsidiary of the pharma.

TScan Therapeutics is looking for strategic partnerships for its heme and autoimmune programs while working to advance two in vivo T cell therapy candidates into investigational new drug–enabling studies.

A new program from ARPA-H has devoted funding to make individualized RNA-based genetic medicine more efficient to produce and improve accessibility.

For $110 million upfront, GSK will have the exclusive global right to advance HMPL-A830, which combines an EGFR-targeting antibody with a small-molecule KRAS blocker. The asset will be studied for colorectal, pancreatic and lung cancer.

Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in Preside…

Almost as many biotechs have opted for a reverse merger to reach the public markets as those executing more traditional initial public offerings this year.

BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers.

After downsizing by 50% last year, Arsenal Biosciences is again laying off employees. This time, 99 people are getting cut as part of a strategic shift to focus the company’s R&D efforts on in vivo CAR T therapies.

Biomarin has granted Ascendis a non-exclusive, worldwide license to use navepegritide, the active ingredient in the latter company’s recently approved achondroplasia drug Yuviwel, in exchange for 18–20% royalties on net sales.